Regulatory Affairs Specialist at Kardium

Drive regulatory excellence with Kardium as a Regulatory Affairs Specialist focused on Change Control. Assess product modifications and collaborate with various teams in a hybrid work setting.

At Kardium, you will evaluate changes affecting regulatory compliance across global markets. This role suits individuals with a strong technical foundation, particularly in mechanical or electrical engineering. You'll work closely with Engineering, Quality, and other teams to ensure all modifications are well-documented and scientifically justified.

Key Responsibilities:
• Assess product and process changes for regulatory impact
• Collaborate with stakeholders to define regulatory requirements
• Review design change and risk assessment documentation
• Support regulatory submissions and technical documentation updates
• Monitor international regulatory requirements and standards

Requirements:
• Bachelor's degree in Engineer...